Febrile Convulsions AE Form

Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Febrile Convulsions - Suspected Signs of Meningitis
Description

Febrile Convulsions - Suspected Signs of Meningitis

Event Number
Description

Please report any febrile convulsion and any suspected signs of meningitis occurring during the study period

Data type

integer

Description
Description

Description

Data type

text

Further Details (For GSK)
Description

Further Details (For GSK)

Event Number
Description

Event Number

Data type

text

Date started
Description

Date started

Data type

date

Date stopped
Description

Date stopped

Data type

date

Intensity
Description

Intensity

Data type

text

Was a neurological examination performed?
Description

Was a neurological examination performed?

Data type

boolean

If Yes, was a lumbar puncture performed?
Description

If Yes, was a lumbar puncture performed?

Data type

boolean

If Yes, date of exam
Description

If Yes, date of exam

Data type

date

Relationship to investigational products
Description

Relationship to investigational products

Data type

boolean

Outcome
Description

Outcome

Data type

text

Similar models

Febrile Convulsions AE Form

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Febrile Convulsions - Suspected Signs of Meningitis
Item
Event Number
integer
Code List
Event Number
CL Item
FC. 1 (1)
CL Item
FC. 2 (2)
Description
Item
Description
text
Item Group
Further Details (For GSK)
Item
Event Number
text
Code List
Event Number
CL Item
FC. 1 (1)
CL Item
FC. 2 (2)
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
text
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Was a neurological examination performed?
Item
Was a neurological examination performed?
boolean
If Yes, was a lumbar puncture performed?
Item
If Yes, was a lumbar puncture performed?
boolean
If Yes, date of exam
Item
If Yes, date of exam
date
Relationship to investigational products
Item
Relationship to investigational products
boolean
Item
Outcome
text
Code List
Outcome
CL Item
Recovered/resolved (1)
CL Item
Recovering/resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered with sequelae/resolved with sequelae (4)